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October 2019

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Subject:
From:
Gabrielle Melancon <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 24 Oct 2019 17:25:30 +0000
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Good Morning, 

 
Does anyone have experience with performing sterility readsfor media fills/aseptic process simulations outside of a 7 day interim read and a 14 day final read? What is you reasoning/justification for needing to do theseadditional reads? 

 I received a recommendation this week to perform morefrequent interim reads of media fill vials with the justification being thatthere could be growth observed in the vial and the organism could then die-off and be re-absorbed intothe TSB resulting in a negative growth observation during the 7 or 14 day read.

 I will admit, I have not heard of a situation where a turbid vialwill turn clear even if the nutrients have been used up and the organism hasdied in the vial. 

Additional input is greatly appreciated, 
Gabrielle

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